Oral Care Strip or Tape and Methods of Use and Manufacture Thereof

ABSTRACT

This invention relates to oral care composition, methods of use and methods of manufacture thereof in the form of a toothtape that can be used to brush or clean teeth and the oral cavity. Particularly, the invention relates to a non-traditional dentifrice that comes in the form of a tape that can, for example, adhere to the oral cavity and particularly the teeth and be dispensed for single use.

BACKGROUND OF THE INVENTION

The formation of dental plaque is a source of gingival and periodontaldisease and subsequent tooth loss. Dental plaque is a mixed matrix ofbacteria, epithelial cells, leukocytes macrophages and other oralexudate. Bacteria comprise approximately three-quarters of the plaquematrix. Any given sample of dental plaque could contain as many as 400different varieties of microorganisms. This mix includes both aerobicand anaerobic bacteria, fungi and protozoa. Viruses have also been foundin samples of dental plaque.

This matrix of organisms and oral exudate continues expanding andcoalesces with other plaque growths situated nearby. The bacteriasynthesize levans and glucans from sucrose found in the oral cavityproviding energy for the microorganisms. These glucans, levans andmicroorganisms form an adhesive skeleton for the continued proliferationof plaque.

Calculus is a yellow or white mineralized deposit of bacterial plaque,inorganic in nature, calculus consists primarily of calcium andmagnesium phosphate and calcium carbonate. Calculus forms in layers asdoes plaque and is simply the mineralization of plaques layeredbacteria. Calculus is formed when plaque's protein-carbohydrate matrixaccumulates calcium followed by the precipitation and mineralization ofcrystalline calcium phosphate. Once mineralized calculus is formed,another layer of bacteria adheres to the surface forming yet anotherlayer of plaque which is subsequently mineralized into calculus.

The failure to retard or stop the proliferation of plaque is detrimentalto oral health. Plaque formation leads to dental caries, gingivalinflammation, periodontal disease and ultimately tooth loss. The presentinventors recognize these problems and have developed a compositionsuitable for combating oral disease, preventing tooth loss, and leadingto general oral well-being.

While the prior art discloses the use of various oral compositions forcombating plaque, there is still a need for additional formulations,which provide greater availability, improved performance in combatingoral disease along with increased user acceptance. The present inventorshave discovered the use of traditional dentifrice ingredients in a basein order to create a non-traditional, portable and consumer desirabletoothtape.

BRIEF SUMMARY OF THE INVENTION

The present invention encompasses oral care products and methods ofusing the same that are effective in arresting the accumulation ofplaque and preventing gingivitis. The invention also encompasses an oralproduct and methods that by reducing plaque will abate subsequentcalculus formation. The invention also encompasses compositions andmethods to provide consumers with a product that will clean the oralcavity and provide improved methods of promoting vitality the oralcavity.

In one embodiment, the invention encompasses an oral care product in theform of a tape or strip that can be utilized to clean the oral cavity.

Another embodiment of the invention encompasses an oral care tape orstrip capable of adhering to the surface of the oral cavity including anamount of oral care composition, wherein said oral care composition iscapable of cleaning the teeth and/or oral cavity.

Another embodiment of the invention encompasses a tape or strip, whichincludes at least one abrasive, at least one surfactant, at least onefoaming agent, and wherein the tape or strip can adhere to the surfaceof the oral cavity and is capable of cleaning the teeth and/or oralcavity, particularly with brushing.

Another embodiment of the invention encompasses a composition includingan oral care tape or strip including at least one abrasive, at least onesurfactant, and at least one fluoride source, wherein the oral care tapeor strip can adhere to the surface of the oral cavity and is capable ofcleaning the teeth and/or oral cavity.

Another embodiment of the invention encompasses a method of cleaning theoral cavity by adhering an oral care tape or strip to the surface of theoral cavity, for example, the teeth, wherein the tape or strip includesat least one abrasive, at least one surfactant, at least one foamingagent and at least one fluoride source, wherein after the tape or stripis adhered to the surface of the oral cavity the oral cavity is brushedto clean the oral cavity.

Another embodiment of the invention encompasses a kit including an oralbrushing tape or strip, which tape or strip is capable of adhering tothe surface of the oral cavity, wherein the oral brushing strip includesat least one abrasive, at least one surfactant, at least one fluoridesource and at least one foaming agent, wherein the oral brushing stripcan adhere to the surface of the oral cavity and is capable of cleaningthe teeth and/or oral cavity, and wherein the kit contains the tape orstrip is predetermined lengths for single use.

To achieve the foregoing and other embodiments and in accordance withthe purpose of the present invention, as embodied and broadly describedherein the oral tape or strip of this invention includes at least oneabrasive, at least one surfactant, at least one fluoride source, and oneor more optional components including vitamins, polymers, enzymes,humectants, preservatives and combinations thereof.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an alternative dispenser for the toothtape of theinvention, and its use.

DETAILED DESCRIPTION OF THE INVENTION

As used throughout, ranges are used as a shorthand for describing eachand every value that is within the range. Any value within the range canbe selected as the terminus of the range. In addition, all referencescited herein are hereby incorporated by reference in their entireties.In the event of a conflict in a definition in the present disclosure andthat of a cited reference, the present disclosure controls.

The invention encompasses an oral tape or strip capable of adhering tothe surface of the oral cavity including an amount of oral carecomposition, wherein said oral care composition. As used herein andunless otherwise indicated, the term “oral care composition” refers to acomposition containing the oral care ingredients described herein. Incertain embodiments, the oral tape or strip includes at least oneabrasive. In another embodiment, the oral tape or strip includes atleast one fluoride ion source. In another embodiment, the oral tape orstrip includes at least one agent to increase the amount of foamgenerated upon use. In another embodiment, the oral tape or stripincludes at least one flavoring agent.

In certain embodiments, the oral tape or strip is contained in a packagein precut segments for single use, which can be adhered to the oralcavity, for example, the teeth, and a source of agitation (such as aconventional toothbrush) is applied to break up and/or aid in thedissolution of the toothtape in the oral cavity. Alternatively, thetoothtape of the invention may be spooled and dispensed by cutting ortrimming a portion of desired length from the spool. The length of thetape may contain perforations or detachable areas at increments so as toallow for easy separation from the length of toothtape.

In another embodiment, the oral tape or strip further includes at leastone vitamin, at least one polymer, at least one fluoride source; alleast one enzyme, at least one humectant, and/or at least onepreservative and combinations thereof.

In certain embodiments, the abrasive includes, but is not limited to,abrasive silica, sodium metaphosphate, potassium metaphosphate,tricalcium phosphate, dihydrated dicalcium phosphate, aluminum silicate,calcined alumina, bentonite or other siliceous materials or combinationsthereof.

In certain embodiments, the fluoride source includes, but is not limitedto sodium fluoride, potassium fluoride, sodium fluorosilicate, sodiummonfluorophosphate (MFP), ammonium fluorosilicate, stannous fluoride andstannous chloride.

In certain embodiments, the agent to increase the amount of foamincludes, but is not limited to, sodium alginate and polyoxyethylene.

In certain embodiments, the flavoring agent is one member chosen fromoil of wintergreen, oil of peppermint, oil of spearmint, oil ofsassafras, oil of clove, aspartame, acesulfame, saccharin, dextrose,levulose and sodium cyclamate and combinations thereof.

In certain embodiments, the abrasive is present in an amount of about 1to 20 wt. %. In certain embodiments, the fluoride source is present inan amount of about 0.01 to 5 wt. %. In certain embodiments, the agent toincrease the amount of foam is present in an amount of about 1 to 90 wt.%. In certain embodiments, the flavoring agent in an amount of about0.01 to 5 wt. %. In certain embodiments, the tape or strip furtherincludes at least one humectant in an amount of about 0.01 to 5 wt. %.

Another embodiment encompasses a composition including an oral brushingtape or strip capable of adhering to the surface of the oral cavity forsingle use, wherein the oral brushing strip has a surface area of about20 to 1000 mm².

The oral care strip or tape compositions may include one or moreabrasives, which may be used in the practice of the invention including,but are not limited to, silica abrasives such as precipitated silicashaving a mean particle size of up to about 20 microns, such as Zeodent115®, marketed by J. M. Huber. Useful abrasives also include sodiummetaphosphate, potassium metaphosphate, tricalcium phosphate, dehydrateddicalcium phosphate, aluminum silicate, calcined alumina, bentonite orother siliceous materials, or combinations thereof. The silica abrasivepolishing materials useful herein as well as the other abrasives,generally have an average particle size ranging between about 0.1 and 30microns, from between 5 and 15 microns. The silica abrasives can be fromprecipitated silica or silica gels, such as the silica xerogelsdescribed in U.S. Pat. No. 3,518,230, to Pader et al, and U.S. Pat. No.3,862,307, to Digiulio, both incorporated herein by reference.Particular silica xerogels are marketed under the trade name Syloid® bythe W. R. Grace & Co., Davison Chemical Division. The precipitatedsilica materials include those marketed by the J. M. Huber Corp. underthe trade name Zeodent®, including the silica carrying the designationZeodent 115 and 119. The silica abrasives are described in U.S. Pat. No.4,340,583, to Wason, incorporated herein by reference.

In certain embodiments, abrasive materials useful in the practice of theoral care strips or tape compositions in accordance with the inventioninclude silica gels and precipitated amorphous silica having an oilabsorption value of about less than 100 cc/100 g silica and in the rangeof from about 45 cc/100 g to 70 cc/100 g silica. Oil absorption valuesare measured using the ASTA Rub-Out Method D281. In certain embodiments,the silicas are colloidal particles having an average particle sizeranging from about 3 microns to 12 microns, and about 5 to 10 microns.

Low oil absorption silica abrasives particularly useful in the practiceof the invention are marketed under the trade designation Sylodent XWA®by Davison Chemical Division of W.R. Grace & Co., Baltimore, Md. 21203,Sylodent 650 XWA®, a silica hydrogel composed of particles of colloidalsilica having a water content of 29% by weight averaging from about 7 to10 microns in diameter, and an oil absorption of less than 70 cc/100 gof silica is an example of a low oil absorption silica abrasive usefulin the practice of the present invention. The abrasive is present in theoral care strip or tape composition of the present invention at aconcentration of about 1 to 40% by weight, in other embodiment about 5to 30% by weight, and in another embodiment about 10 to 20% by weight.The dosage of abrasive in the individual strip or tape (i.e., a singledose) is about 0.01 to 0.4% by weight, 0.05 to 0.3% by weight, and inanother embodiment about 0.1 to 0.2% by weight.

The oral care strip or tape compositions may further include one or morefluoride ion sources. A wide variety of fluoride ion-yielding materialscan be employed as sources of soluble fluoride in the presentcompositions. Examples of suitable fluoride ion-yielding materials arefound in U.S. Pat. No. 3,535,421, to Briner et al.; U.S. Pat. No.4,885,155, to Parran, Jr. et al. and U.S. Pat. No. 3,678,154, to Widderet al., incorporated herein by reference.

Representative fluoride ion sources include, but are not limited to,stannous fluoride, sodium fluoride, potassium fluoride, sodiummonofluorophosphate, sodium fluorosilicate, sodium monfluorophosphate(MFP), ammonium fluorosilicatc, as well as tin fluorides, such asstannous fluoride and stannous chloride, and combinations thereof.Certain particular embodiments include stannous fluoride or sodiumfluoride as well as mixtures thereof.

In certain embodiments, the oral care strip or tape oral composition ofthe invention may also contain a source of fluoride ions orfluorine-providing ingredient in amounts sufficient to supply about 25ppm to 5,000 ppm of fluoride ions.

Fluoride ion sources may be added to the compositions of the inventionat a level of from about 0.01 to 3.0% in one embodiment or from about0.03% to 1.0%, by weight of the composition in another embodiment. Thedosage of the individual strip or tape (i.e., a single dose) is about0.0001 to 0.003% by weight, 0.0005 to 0.003% by weight, and in anotherembodiment about 0.001 to 0.02 by weight.

The oral care strips or tape compositions of the invention also mayinclude an agent to increase the amount of foam that is produced whenthe strip or tape adhered to the oral cavity is brushed or otherwiseagitated.

Illustrative examples of agents that increase the amount of foaminclude, but are not limited to polyoxyethylene and certain polymersincluding, but not limited to, alginate polymers.

The polyoxyethylene may increase the amount of foam and the thickness ofthe foam generated by the oral care carrier component of the presentinvention. Polyoxyethylene is also commonly known as polyethylene glycol(“PEG”) or polyethylene oxide. The polyoxyethylenes suitable for thisinvention will have a molecular weight of about 200,000 to about7,000,000. In one embodiment the molecular weight will be from about600,000 to about 2,000,000 and in another embodiment from about 800,000to about 1,000,000. Polyox® is the trade name for the high molecularweight polyoxyethylene produced by Union Carbide.

The Polyoxyethylene may be present in an amount from about 1% to 90%, inone embodiment from about 5% to 50% and in another embodiment from about10% to 20% by weight of the oral care carrier component of the oral carecompositions of the present invention. The dosage of foaming agent inthe individual strip or tape (i.e., a single dose) is about 0.01 to 0.9%by weight, 0.05 to 0.5% by weight, and in another embodiment about 0.1to 0.2% by weight.

Another agent optionally included in the oral care tape or strips of theinvention is a surfactant or a mixture of compatible surfactants.Suitable surfactants are those which are reasonably stable through awide pH range, for example, anionic, cationic, nonionic or zwitterionicsurfactants.

Suitable surfactants are described more fully, for example, in U.S. Pat.No. 3,959,458, to Agricola et al.; U.S. Pat. No. 3,937,807, to Haefele;and U.S. Pat. No. 4,051,234, to Gieske et al., which are incorporatedherein by reference.

In certain embodiments, the anionic surfactants useful herein includethe water-soluble salts of alkyl sulfates having from 10 to 18 carbonatoms in the alkyl radical and the water-soluble salts of sulfonatedmonoglycerides of fatty acids having from 10 to 18 carbon atoms. Sodiumlauryl sulfate, sodium lauroyl sarcosinate and sodium coconutmonoglyceride sulfonates are examples of anionic surfactants of thistype. Mixtures of anionic surfactants may also be utilized.

In another embodiment, cationic surfactants useful in the presentinvention can be broadly defined as derivatives of aliphatic quaternaryammonium compounds having one long alkyl chain containing from about 8to 18 carbon atoms such as lauryl trimethylammonium chloride, cetylpyridinium chloride, cetyl trimethylammonium bromide,di-isobutylphenoxyethyldimethylbenzylammonium chloride, coconutalkyltrimethylammonium nitrite, cetyl pyridinium fluoride, and mixturesthereof.

Illustrative cationic surfactants are the quaternary ammonium fluoridesdescribed in U.S. Pat. No. 3,535,421, to Briner et al., hereinincorporated by reference. Certain cationic surfactants can also act asgermicides in the compositions.

Illustrative nonionic surfactants that can be used in the compositionsof the invention can be broadly defined as compounds produced by thecondensation of alkylene oxide groups (hydrophilic in nature) with anorganic hydrophobic compound which may be aliphatic or alkylaromatic innature. Examples of suitable nonionic surfactants include, but are notlimited to, the Pluronics, polyethylene oxide condensates of alkylphenols, products derived from the condensation of ethylene oxide withthe reaction product of propylene oxide and ethylene diamine, ethyleneoxide condensates of aliphatic alcohols, long chain tertiary amineoxides, long chain tertiary phosphine oxides, long chain dialkylsulfoxides and mixtures of such materials.

In certain embodiments, zwitterionic synthetic surfactants useful in thepresent invention can be broadly described as derivatives of aliphaticquaternary ammonium, phosphonium, and sulfonium compounds, in which thealiphatic radicals can be straight chain or branched, and wherein one ofthe aliphatic substituents contains from about 8 to 15 carbon atoms andone contains an anionic water-solubilizing group, e.g., carboxy,sulfonate, sulfate, phosphate or phosphonate. Illustrative examples ofthe surfactants suited for inclusion into the composition include, butare not limited to, sodium alkyl sulfate, sodium lauroyl sarcosinate,cocoamidopropyl betaine and polysorbate 20, and combinations thereof.

The surfactant or mixtures of compatible surfactants can be present inthe compositions of the present invention from about 0.1% to about 5.0%,in another embodiment from about 0.3% to about 3.0% and in anotherembodiment from about 0.5% to about 2.0% by weight of the totalcomposition. The dosage of surfactant in the individual strip or tape(i.e., a single dose) is about 0.001 to 0.05% by weight, 0.003 to 0.03%by weight, and in another embodiment about 0.005 to 0.02% by weight.

The oral care strips or tape compositions of the invention may alsoinclude a flavoring agent. Flavoring agents which are used in thepractice of the present invention include, but are not limited to,essential oils as well as various flavoring aldehydes, esters, alcohols,and similar materials. Examples of the essential oils include oils ofspearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus,marjoram, cinnamon, lemon, lime, grapefruit, and orange. Also useful aresuch chemicals as menthol, carvone, and anethole. Certain embodimentsemploy the oils of peppermint and spearmint.

The flavoring agent is incorporated in the oral composition at aconcentration of about 0.1 to about 5% by weight and about 0.5 to about1.5% by weight. The dosage of flavoring agent in the individual strip ortape (i.e., a single dose) is about 0.001 to 0.05% by weight and inanother embodiment about 0.005 to 0.015% by weight.

The oral care strips or tape compositions of the invention may alsoinclude one or more adhesive agents to aid the tape or strip to adhereto the tissues of the oral cavity. Suitable adhesives include, but arenot limited to, both polymers with limited water solubility as well aspolymers lacking water solubility. These polymers deposit a thin film onboth the oral cavity's soft and hard tissues when saliva combines withthe instant composition. Suitable limited water solubility adhesivesinclude, but are not limited to, hydroxy ethyl or propyl cellulose.Adhesives lacking water solubility and suitable for the compositions ofthe invention include, but are not limited to, ethyl cellulose, polyoxresins and silicones. Adhesives lacking water solubility areincorporated into the instant invention by using a small amount of ethylalcohol or another alcohol safe for use in the oral cavity and the humanbody.

Another possible adhesive suitable for use in the instant composition ispolyvinylpyrrolidone (“PVP”) with a molecular weight of about 50,000 toabout 300,000, a suitable PVP is available from GAF ChemicalsCorporation.

Still another possible adhesive suitable for use in the instantcomposition is a combination of Gantrez and the semisynthetic,water-soluble polymer carboxymethyl cellulose (“CMC”). Certainembodiments encompass a mixture of 2:1 to 1:1 (Gantrez to CMC). Suitablefor use in the combination is Gantrez with a M.W. of about 30,000 toabout 1,000,000 available from GAF Chemicals Corporation and CMC with aM.W. of about 90,000 to about 700,000 available from Aqualon Company.

The oral care strips or tape compositions of the invention also mayoptionally include one or more chelating agents able to complex calciumfound in the cell walls of the bacteria. Binding of this calcium weakensthe bacterial cell wall and augments bacterial lysis.

Another group of agents suitable for use as chelating agents in thepresent invention are the soluble pyrophosphates. The pyrophosphatesalts used in the present compositions can be any of the alkali metalpyrophosphate salts. In certain embodiments, salts include tetra alkalimetal pyrophosphate, dialkali metal diacid pyrophosphate, trialkalimetal monoacid pyrophosphate and mixtures thereof, wherein the alkalimetals are sodium or potassium. The salts are useful in both theirhydrated and unhydrated forms. An effective amount of pyrophosphate saltuseful in the present composition is generally enough to provide atleast 1.0% pyrophosphate ions, from about 1.5% to about 6%, from about3.5% to about 6% of such ions. The dosage chelating agent in theindividual strip or tape (i.e., a single dose) is about 0.01 to 0.6% byweight and in another embodiment about 0.035 to 0.06% by weight.

The oral care strips or tape compositions of the invention alsooptionally include one or more polymers. Such materials are well knownin the art, being employed in the form of their free acids or partiallyor fully neutralized water soluble alkali metal (e.g. potassium andsodium) or ammonium salts. Certain embodiments include 1:4 to 4:1copolymers of maleic anhydride or acid with another polymerizableethylenically unsaturated monomer, for example, methyl vinyl ether(methoxyethylene) having a molecular weight (M.W.) of about 30,000 toabout 1,000,000. These copolymers are available for example as GantrezAN 139 (M.W. 500,000), AN 119 (M.W. 250,000) and S-97 PharmaceuticalGrade (M.W. 70,000), of GAF Chemicals Corporation.

Other operative polymers include those such as the 1:1 copolymers ofmaleic anhydride with ethyl acrylate, hydroxyethyl methacrylate,N-vinyl-2-pyrollidone or ethylene, the latter being available forexample as Monsanto EMA No. 1103, M.W. 10,000 and EMA Grade 61, and 1:1copolymers of acrylic acid with methyl or hydroxyethyl methacrylate,methyl or ethyl acrylate, isobutyl vinyl ether or N-vinyl-2-pyrrolidone.

Suitable generally, are polymerized olefinically or ethylenicallyunsaturated carboxylic acids containing an activated carbon-to-carbonolefinic double bond and at least one carboxyl group, that is, an acidcontaining an olefinic double bond which readily functions inpolymerization because of its presence in the monomer molecule either inthe alpha-beta position with respect to a carboxyl group or as part of aterminal methylene grouping. Illustrative of such acids are acrylic,methacrylic, ethacrylic, alpha-chloroacrylic, crotonic, beta-acryloxypropionic, sorbic, alpha-chlorsorbic, cinnamic, beta-styrylacrylic,muconic, itaconic, citraconic, mesaconic, glutaconic, aconitic,alpha-phenylacrylic, 2-benzyl acrylic, 2-cyclohexylacrylic, angelic,umbellic, fumaric, maleic acids and anhydrides. Other different olefinicmonomers copolymerizable with such carboxylic monomers includevinylacetate, vinyl chloride, dimethyl maleate and the like. Copolymerscontain sufficient carboxylic salt groups for water-solubility.

A further class of polymeric agents includes a composition containinghomopolymers of substituted acrylamides and/or homopolymers ofunsaturated sulfonic acids and salts thereof, in particular wherepolymers are based on unsaturated sulfonic acids selected fromacrylamidoalykane sulfonic acids such as 2-acrylamide 2 methylpropanesulfonic acid having a molecular weight from 1,000-2,000,000, describedin U.S. Pat. No. 4,842,847, Jun. 27, 1989 to Zahid, incorporated hereinby reference.

Another useful class of polymeric agents includes polyamino acids,particularly those containing proportions of anionic surface-activeamino acids such as aspattic acid, glutamic acid and phosphoserine, asdisclosed in U.S. Pat. No. 4,866,161 Sikes et al., incorporated hereinby reference.

The oral care strips or tape compositions of the invention may alsooptionally include one or more enzymes. Useful enzymes include any ofthe available proteases, glucanohydrolases, endoglycosidases, amylases,mutanases, lipases and mucinases or compatible mixtures thereof. Incertain embodiments, the enzyme is a protease, dextranase,endoglycosidase and mutanase. In another embodiment, the enzyme ispapain endoglycosidase or a mixture of dextranase and mutanase.Additional enzymes suitable for use in the present invention aredisclosed in U.S. Pat. No. 5,000,939 to Dring et al., U.S. Pat. No.4,992,420; U.S. Pat. No. 4,355,022; U.S. Pat. No. 4,154,815; U.S. Pat.No. 4,058,595; U.S. Pat. No. 3,991,177; and U.S. Pat. No. 3,696,191 allincorporated herein by reference. An enzyme of a mixture of severalcompatible enzymes in the current invention constitutes from about0.002% to about 2.0% in one embodiment or from about 0.05% to about 1.5%in another embodiment or in yet another embodiment from about 0.1% toabout 0.5%.

Water may also be present in the oral compositions of the invention.Water, employed in the preparation of commercial oral compositionsshould be deionized and free of organic impurities. Water commonly makesup the balance of the compositions and includes from about 10% to 50%,about 20% to 40% or about 10% to 15% by weight of the oral compositions.This amount of water includes the free water which is added plus thatamount which is introduced other materials such as with sorbitol or anycomponents of the invention.

In preparing oral care strips or tape compositions, it is sometimesnecessary to add some thickening material to provide a desirableconsistency. In certain embodiments, the thickening agents arecarboxyvinyl polymers, carrageenan, hydroxyethyl cellulose and watersoluble salts of cellulose ethers such as sodium carboxymethyl celluloseand sodium carboxymethyl hydroxyethyl cellulose. Natural gums such askaraya, gum arabic, and gum tragacanth can also be incorporated.Colloidal magnesium aluminum silicate or finely divided silica can beused as component of the thickening composition to further improve thecomposition's texture. Thickening agents in an amount from 0.5% to 5.0%by weight of the total composition can be used.

Within certain embodiments of the oral compositions, it is alsodesirable to incorporate a humectant to prevent the composition fromhardening upon exposure to air. Certain humectants can also impart,desirable sweetness or flavor to dentifrice compositions. The humectant,on a pure humectant basis, generally includes from about 15% to 70% inone embodiment or from about 30% to 65% in another embodiment by weightof the dentifrice composition.

Suitable humectants include edible polyhydric alcohols such asglycerine, sorbitol, xylitol, propylene glycol as well as other polyolsand mixtures of these humectants. Mixtures of glycerine and sorbitol maybe used in certain embodiments as the humectant component of thetoothpaste compositions herein.

In addition to the above described components, the embodiments of thisinvention can contain a variety of optional dentifrice ingredients someof which are described below. Optional ingredients include, for example,but are not limited to, adhesives, sudsing agents, flavoring agents,sweetening agents, additional antiplaque agents, abrasives, and coloringagents. These and other optional components are further described inU.S. Pat. No. 5,004,597, to Majeti; U.S. Pat. No. 3,959,458 to Agricolaet al. and U.S. Pat. No. 3,937,807, to Haefele, all being incorporatedherein by reference.

The compositions of the present invention can be made using methodswhich are common in the oral product area.

In one illustrative embodiment, the toothtape is made by dissolvingacrylate copolymers and PVP In ethanol and mixing for 2 minutes at 2600rpm to form Premix 1.

Actives such as, for example, vitamins, CPC, fluoride, abrasives, andany other desired active ingredients are added to Premix 1 and mixed for2 minutes at 2000 rpm to form Premix 2.

A toothpaste base is added to Premix 2 and mixed for 2 minutes al 3000rpm. The final slurry is cast on hydrophobic surface with approximately0.2 mm wet thickness. Film is dried in air-circulating oven at about175-180° C. for 1-2 hr.

The present invention in its method aspect involves applying to the oralcavity a safe and effective amount of the compositions described herein.These amounts, for example, from about 20 mm² to 2000 mm² of the stripor tape, is kept in the mouth from about 15 seconds to about 12 hours.In addition, the oral care strip or tape can be left alone to clean theteeth or can be used with a brush.

The following examples further describe and demonstrate illustrativeembodiments within the scope of the present invention. The examples aregiven solely for illustration and are not to be construed as limitationsof this invention as many variations are possible without departing fromthe spirit and scope thereof.

EXAMPLES Example 1 Example 1 illustrates illustrative embodiments of thecompositions for “Toothtape” for the dentifrice and for a single dosage.In certain embodiments, the single dosage may be a precut or aperforated strip to allow the user to easily use a strip with apredetermined dosage. In other embodiments, the strips are not precutand the user can tear or cut the strip in a desired length.

TABLE 1 wt./1 g dentifrice Ingredient % in dentifrice or 1 dosetoothtape Abrasive 10.00 0.100 Flavor 0.30 0.003 SLS 0.50 0.005Saccharin 0.30 0.003 Sorbitol (70%) 10.00 0.100 Alginate Polymer 20-78.90.2-0.789 Water Balance BalanceThe toothtape dose has an approximate surface area of about 200 mm² (40mm×5 mm when applied to upper front teeth.

Example 2 Example 2 illustrates various illustrative embodiments of thetoothtape and Table 1 illustrates the sensory perception of theembodiments based on the average of 5 panelists.

TABLE 2 Formula Formula Formula Formula Formula Formula A B C D E FAbrasive 10.00 10.00 10.00 10.00 20.00 15.00 Flavor 0.40 0.00 0.30 0.300.00 0.40 SLS 0.50 0.50 0.50 0.50 0.40 0.40 Saccharin 0.20 0.00 0.300.30 0.40 0.10 Sorbitol 0.00 0.00 0.00 0.00 0.00 0.00 Alginate 20.0020.00 30.00 30.00 40.00 40.00 Polymer Water Balance Balance BalanceBalance Balance Balance

TABLE 3 Comments Amount Level of Avg. of 5 Sample Structure AdhesionDissolution of foam Residue flavor Bitterness panelists Formula A 3.253.75 4.25 4.25 4.0 2.25 3.0 best flavor Formula B 3.0 3.75 3.0 4.5 2.61.0 2.25 worse taste Formula C 3.75 3.5 3.75 4.5 4.3 1.5 3.25 No flavorFormula D 3.75 3.25 3.9 4.5 3.75 1.75 3.0 No flavor Formula E 2.8 1.62.9 4.0 4.2 3.4 4.5 sweet, no flavor, little bitter Formula F 2.3 2.52.9 4 4.2 1.5 2.8 very sweet, no flavor, very bitter Keys: Structure:Brittle = 1, Pliable = 5. Adhesion: Poor = 1, Good = 5. Should adherewell before brushing and then remain until it dissolves with brushing.Dissolution: Poor = 1, Good = 5. Target is 20-30 s to completedissolution. Amount of foam: Poor = 1, Good = 5. Target is same as akid's dentifrice. Residue: Lot = 1, None = 5. Target is none. Levels offlavor: None = 1, Strong = 5. Bitterness: Lot = 1, None = 5. Target isnone.

Example 3

Example 3 illustrates various illustrative embodiments of the toothtapeof the invention for immediate release.

TABLE 4 TOOTHTAPE compositions for Immediate Release of Actives FormulaFormula Formula Formula Formula Ingredient A % B % C % D % E %Polyethylene glycol 600 1.55 1.56 3.99 4.49 3.08 Sodium CMC 0.31 0.310.47 0.44 0.16 CP purified water 3.64 3.66 5.51 5.18 3.08 SodiumSaccharin USP 0.155 0.156 0.23 0.22 0.13 Tetrasodium 0.26 0.26 0.12 0.370.22 Pyrophosphate FD&Blue no. 1-1% soln 0.083 0.083 0.125 0.12 0.07Sorbitol-non- 31.4 31.53 50.16 47.43 26.56 crystalizing-NF Syntheticglycerin — — 4.73 6.98 2.96 Sodium Fluoride 0.124 0.125 0.19 0.18 0.11Abrasive silica 13.19 19.86 20.92 19.64 12.18 (Zeodent 115) LiquidFlavor 0.37 0.37 0.56 0.53 0.31 Sodium Lauryl Sulfate 0.62 0.81 1.18 1.20.86 Spray-dried Flavor — — 0.11 0.4 0.83 Acrylic copolymers 12.7813.175 0.85 1.13 13.25 Polyvinylpyrrolidone 3.83 2.14 0.76 0.54 3.79Vitamin E — — 0.3 0.33 0.33 Vitamin E-acetate — — 0.04 0.085 0.13Vitamin B₅ — — 0.03 0.06 0.07 Vitamin C (ascorbyl — — 0.013 0.02 0.03palmitate) Folic Acid — — — 0.03 0.02 CPC — 0.1 — — — Triclosan — — — —— Ethanol 31.688 25.861 9.712 10.63 31.83 Total 100 100 100 100 100Final weight (gr) 35.47 77.05 84.26 91.7 84.5Other actives can be used, including: cholorhexidine, gluconate,solbrol, enzymes such as GOX, HOX, tannase, papain; glucoamylase,hydrogen peroxide, Q10, biotin, vitamins A and D, stannous fluoride,zinc citrate, essential oils, herbals such as magnolia, rosemary, greentea.

Example 4

Example 4 illustrates various illustrative embodiments of the toothtapeof the invention for sustained release.

TABLE 5 TOOTHTAPE compositions for Sustained Release of Actives FormulaFormula Formula Formula Formula Formula Ingredient A % B % C % D % E % F% Polyethylene glycol 600 1.55 1.55 1.55 1.55 1.55 1.55 Sodium CMC 0.310.31 0.31 0.31 0.31 031 CP purified water 3.64 3.64 3.64 3.64 3.64 3.64Sodium Saccharin USP 0.155 0.155 0.155 0.155 0.155 0.155 tetrasodumPyrophosphate 0.26 0.26 0.26 0.26 0.26 0.26 FD&Blue no. 1-1% soln 0.0830.083 0.083 0.083 0.083 0.083 Sorbitol-non-crystalizing-NF 31.40 31.4031.40 31.40 31.40 31.40 (70% soln) Synthetic glycerin — — — — — — SodiumFluoride 0.124 0.124 0.124 0.124 0.124 0.124 Abrasive Silica (zeodent115) 10.00 10.00 15.00 15.00 10.00 10.00 Prophy 15.50 15.50 10.50 10.5015.50 15.50 Liquid Flavor 3.00 3.00 3.00 3.00 — — Sodium Lauryl Sulfate1.20 1.20 1.20 1.20 1.20 1.20 Spray-dried Flavor — — — — 3.00 3.00Acrylic Copolymers 12.00 12.00 12.00 12.00 12.00 12.00Polyvinylpyrrolidone 3.00 3.00 3.00 3.00 3.00 3.00 Chitosan 5.00 5.005.00 5.00 5.00 5.00 Vitamin E 2.00 — 2.00 — 2.00 — Vitamin E-acetate0.20 — 0.20 — 0.20 — Vitamin B₅ 0.05 — 0.05 — 0.05 — Vitamin C (ascorbylpalmitate) 0.05 — 0.05 — 0.05 — Folic Acid 0.05 — 0.05 — 0.05 — CPC 0.020.02 0.02 0.02 0.02 0.02 Ethanol 10.41 12.76 10.41 12.76 10.41 12.76Total 100 100 100 100 100 100

hat is claimed is:
 1. A composition comprising an oral brushing tape orstrip capable of adhering to the surface of the oral cavity, wherein theoral brushing strip comprises: (i) at least one abrasive; (ii) at leastone surfactant; (iii) at least one fluoride source; and wherein the oralbrushing strip can adhere to the surface of the oral cavity and iscapable of cleaning the teeth and/or oral cavity.
 2. The oral tape orstrip of claim 1 comprising at east one agent to increase the amount offoam.
 3. The oral tape or strip of claim 1, wherein the tape or film isin precut segments.
 4. The oral tape or strip of claim 1 furthercomprising at least one vitamin, at least one polymer, at least oneflavoring agent; at least one enzyme, at least one humectant, and/or atleast one preservative and combinations thereof.
 5. The oral tape orstrip of claim 1, wherein the abrasive is one member chosen fromabrasive silica, sodium metaphosphate, potassium metaphosphate,tricalcium phosphate, dihydrated dicalcium phosphate, aluminum silicate,calcined alumina, bentonite or other siliceous materials, orcombinations thereof.
 6. The oral tape or strip of claim 1, wherein thefluoride source is one member chosen from sodium fluoride, potassiumfluoride, sodium fluorosilicate, sodium monfluorophosphate (MFP),ammonium fluorosilicate, stannous fluoride and stannous chloride.
 7. Theoral tape or strip of claim 2, wherein the agent to increase the amountof foam is one member chosen from sodium alginate and polyoxyethylene.8. The oral tape or strip of claim 4, wherein the flavoring agent is onemember chosen from oil of wintergreen, oil of peppermint, oil ofspearmint, oil of sassafras, oil of clove, aspartame, acesulfame,saccharin, dextrose, levulose and sodium cyclamate and combinationsthereof.
 9. A oral tape or strip capable of adhering to the surface ofthe oral cavity comprising: (i) at least one abrasive; (ii) at least onesurfactant; (iii) at least one foaming agent; and wherein the tape orfilm can adhere to the surface of the oral cavity and is capable ofcleaning the teeth and/or oral cavity.
 10. The oral tape or strip ofclaim 9, wherein the tape or film is in precut segments.
 11. The oraltape or strip of claim 9, further comprising at least one vitamin,flavoring agent, at least one polymer, at least one fluoride source; atleast one enzyme, and/or at least one preservative or combinationsthereof.
 12. The oral tape or strip of claim 9, wherein the abrasive isabrasive silica, sodium metaphosphate, potassium metaphosphate,tricalcium phosphate, dihydrated dicalcium phosphate, aluminum silicate,calcined alumina, bentonite or other siliceous materials, orcombinations thereof.
 13. The oral tape or strip of claim 9, wherein thefluoride source is one member chosen from sodium fluoride, potassiumfluoride, sodium fluorosilicate, sodium monfluorophosphate (MFP)ammonium fluorosilicate, stannous fluoride and stannous chloride. 14.The oral tape or strip of claim 9, wherein the agent to increase theamount of foam is one member chosen from sodium alginate andpolyoxyethylene.
 15. The oral tape or strip of claim 9, wherein theflavoring agent is one member chosen from oil of wintergreen, oil ofpeppermint, oil of spearmint, oil of sassafras, oil of clove, aspartame,acesulfame, saccharin, dextrose, levulose and sodium cyclamate andcombinations thereof.
 16. The oral tape or strip of claim 9, wherein theat least one abrasive is present in an amount of about 1 to 20 wt. % 17.The oral tape or strip of claim 9, wherein the at least one fluoridesource is present in an amount of about 0.01 to 5 wt. %
 18. The oraltape or strip of claim 9, wherein the at least one agent to increase theamount of foam is present in an amount of about 1 to 90 wt. %
 19. Theoral tape or strip of claim 9 further comprising at least one flavoringagent in an amount of about 0.01. to 5 wt. %.
 20. The oral tape or stripof claim 9 further comprising at least one humectant in an amount ofabout 0.01 to 5 wt. %.